AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED is an FDA 510(k)-cleared medical device (K941981) manufactured by W. L. Gore & Associates, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 1994. Regulation: 8.